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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENDURO MENISCAL COMPONENT F2 16MM KNEE ENDOPROSTHETICS

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AESCULAP AG ENDURO MENISCAL COMPONENT F2 16MM KNEE ENDOPROSTHETICS Back to Search Results
Model Number NR883M
Device Problems Fracture (1260); Patient Device Interaction Problem (4001)
Patient Problems Failure of Implant (1924); Implant Pain (4561)
Event Date 08/09/2020
Event Type  Injury  
Manufacturer Narrative
Investigation on going. Additional information / results will be submitted in a supplemental report.
 
Event Description
It was reported that there was an issue with enduro meniscal. According to the complaint description, it was reported that fracture of axis occured. Both axis and inlay changed. The primary implantation of the prosthesis was on (b)(6) 2012 in the (b)(6). The first inlay and axis revision due to suspicion of infection was on (b)(6) 2014, the second for the same reason on (b)(6) 2017, both in (b)(6). Now the third revision on (b)(6) 2020, the axis and the inlay changed, but the existing locknut was reused. Additional information has been requested but not yet received as of this report. Additional patient information is not available. The adverse event / malfunction is filed under aag reference (b)(4).
 
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Brand NameENDURO MENISCAL COMPONENT F2 16MM
Type of DeviceKNEE ENDOPROSTHETICS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key10563903
MDR Text Key208341739
Report Number9610612-2020-00490
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K101815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Model NumberNR883M
Device Catalogue NumberNR883M
Device Lot Number52336148
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/21/2020 Patient Sequence Number: 1
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